Monday, February 8, 2021

FDA Approves Labeling Update for Abbott’s HeartMate 3 Heart Pump for use in Pediatric Patients


The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more options for treating the pediatric population awaiting a heart transplant or ineligible for receiving a transplant due to complications, according to a news release.


Heart Mate 3 initially received U.S. approval in 2017 for adults awaiting a heart transplant, then it received long-term use approval for adults in 2018. The left ventricular assist device (LVAD) is implanted to pump blood through the body for those who have hearts too weak to do so in their own.


Abbott Park, Ill.-based Abbott said the updated labeling follows a trend of pediatric innovations for the company, with its Masters HP heart valve approved in 2018 and its Amplatzer Piccolo occluder cleared in 2019, both for pediatric populations.


“For families with children battling chronic diseases the future is often bleak. As physicians, we see the fear in the eyes of not only the child, but also the mothers and fathers,” divisional VP of global medical affairs in Abbott’s heart failure business Dr. Robert L. Kormos said in the release. “Imagine a child with a heart condition that does not allow them to play with friends, sing or run. Innovations, such as the Heart Mate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life.”

Many children and adolescents with congestive heart failure require a heart transplant or mechanical device implant to survive. The Heart Mate 3 left ventricular assist device (LVAD) – or heart pump – is an implantable device that pumps blood through the body in people whose heart is too weak to do so on its own. The Heart Mate 3 pump was initially approved in the United States in 2017 for adults awaiting a heart transplant and received FDA approval for long-term use in adults in 2018. In the largest LVAD trial in the world, the Heart Mate 3 pump showed a survival rate of 79% at two years – an outcome comparable to patients receiving a heart transplant.


"For families with children battling chronic diseases the future is often bleak. As physicians, we see the fear in the eyes of not only the child, but also the mothers and fathers," said Robert L. Kormos, M.D., divisional vice president, global medical affairs, Abbott's heart failure business. "Imagine a child with a heart condition that does not allow them to play with friends, sing or run. Innovations, such as the Heart Mate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life."

Contact: cardionheart@gmail.com

Tuesday, February 2, 2021

Marizyme Announces the Use of DuraGraft® as the Standard-of-Care in Patients Undergoing Coronary Artery Bypass Surgery (CABG) at Vienna Heart Center North Floridsdorf

Vienna Heart Center leverages Marizyme’s DuraGraft as the Standard-of-Care in Patients Undergoing Coronary Artery Bypass Surgery

#Cardiac #cardiologist #doctor #cardio #cardiovascular #ECG #HeartNews #healthcare #medicaltechnology


A global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, today announced as of August 2020 the Vienna Heart Center North Floridsdorf of Vienna, Austria was the first clinic worldwide to use the company's flagship product, DuraGraft® as the standard-of-care for flushing and storage of the saphenous vein grafts from harvesting through grafting in Coronary Artery Bypass Grafting (CABG) patients.

Vienna Heart Center North Floridsdorf, an internationally recognized leader, is Austria's latest super-specialty center. Opening in 2019, it is one of Europe's most modern Centers. The hospital has a Heart and Vascular Center with a focus on aortic procedures and minimally invasive cardiovascular procedures and all techniques of CABG. The center performs approximately 500 CABG surgeries per year and is part of the ongoing DuraGraft EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits with DuraGraft to Evaluate the Safety and Performance of DuraGraft (VASC). Based on the performance of DuraGraft in improving patient outcomes, the Cardiac Surgery Center at Vienna Heart Center North Floridsdorf in August 2020 recognized DuraGraft as the standard-of-care for CABG surgeries.

"We have seen encouraging evidence that reinforces the importance of appropriate graft treatment during surgery and the role of DuraGraft in significantly improving outcomes in all patients. Additionally, we have observed significant myocardial protection utilizing DuraGraft during CABG, where we have implemented a recent study," said Associate Professor Priv. Doz. Dr. Bernhard Winkler at Vienna Heart Center North Floridsdorf.

The Chief of Cardiac Surgery at the hospital, Prof. Dr. Martin Grabwenwöger, said, "Saline, blood and buffered solutions have long been considered the standard-of-care for CABG surgery; however, studies have shown that DuraGraft outperforms its predecessors. We are thrilled to have DuraGraft as our new standard-of-care for graft treatments during CABG Surgery."

"The endothelial damage inhibitor, DuraGraft, has shown promising results in several preclinical studies and large-scale clinical investigations to adequately protect and preserve vascular conduits and in improving clinical outcomes. Therefore, its use as standard-of-care for vascular conduit storage and prevention of ischemic injury is not surprising," said Prof. Dr. Maximilian Emmert from the German Heart Center Berlin, Germany and PI of the VASC Registry.

Dr. Neil J. Campbell, Chief Executive Officer of Marizyme, stated, "Clinical evidence generated by independent researchers around the world have shown that DuraGraft improves CABG clinical outcomes resulting in DuraGraft providing a value proposition to patients, cardiac centers and healthcare systems worldwide. We at Marizyme are extremely excited to offer this product to CABG patients."

About CABG and DuraGraft When patients with heart disease undergo CABG surgery, free vein or arterial grafts harvested from the leg, arm or chest are frequently used to bypass occluded coronary arteries; about 90% of CABG surgeries use at least one free vein graft. In most cases, in the time between harvesting and bypass grafting, the free graft is stored in saline or autologous blood which do not protect the graft from ischemic injury thereby increasing the risk of ischemia-reperfusion injury and graft disease and ultimate failure leading to post-CABG myocardial infarction and the need for repeat revascularization procedure.

DuraGraft is a CE-marked product that protects vascular grafts against ischemic injury and is the only product approved for graft protection and preservation during bypass and other vascular surgeries. DuraGraft protects graft tissue from harvesting through anastomosis and is used during vascular surgery (including CABG) as a treatment to maintain the structural and functional integrity of isolated vascular grafts. The use of DuraGraft is associated with the reduction of post-CABG complications associated with graft disease and failure: Myocardial Infarction, Repeat Revascularization, and MACE.

Clinical studies in more than 3,000 patients support the long-term safety and efficacy of DuraGraft. The use of DuraGraft in CABG surgery is associated with statistically significant lower risks for clinical complications following CABG; 45% reduction in non-fatal myocardial infarction (MI) (p <.0001), 35% reduction in repeat revascularization (p=0.037), and 19% reduction of MACE (a composite of all major adverse cardiac events)

About Vienna Heart Center North Floridsdorf The latest super-specialty heart center, one of the most modern centers in Europe, 800 beds with a large unit together cardio-vascular, interventional radiology, cardiology.

About Marizyme, Inc. Marizyme, Inc. is a development-stage company dedicated to the commercialization of therapies that address the urgent need relating to higher mortality and costs in the acute care space. Specifically, Marizyme will focus its efforts on developing and acquiring treatments for those diseases. Through its recent acquisition of Somahlution it has acquired products and product candidates that reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant, and other surgical indications. The company's flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications associated with graft failure. DuraGraft enhances CABG surgical outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction. For More Information visit: https://heartcongress.healthconferences.org

Forward-Looking Statements This press release may contain certain forward-looking statements, including those relating to the Marizyme's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company's control, affect the Company's operations, performance, business strategy and results and there can be no assurances that the Company's actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. Forward-looking statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, including those risks set forth in the Company's risk factor disclosure in its Registration Statement on Form 10K filed with the Securities and Exchange Commission (SEC File No. 000-53223), uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. 

Contact: cardionheart@gmail.com


Monday, March 16, 2020

34th World Congress on Heart Diseases

Crowd Reviews Partnered with Pulsus to Announce: Unleash the Enigma in Cardiology/ Heart Diseases through Heart Congress 2020

Pulsus Group hosts the 34th World Congress on Heart Diseases (Heart Congress 2020) that discusses the new paradigm approach to probe every single element in Cardiology/ Heart Disease. Heart Congress 2020 focuses on many interactive scientific sessions on different types of Blood disorders and Cancers as well as various diagnostic and therapeutic advancements in this field. It also provides an opportunity to showcase your ingenuity to the world. Heart Congress 2020 will be organized around the theme “Renovation to Modulate the pulse that beats for your life” on July 27- 28, 2020 at Madrid, Spain.

The major focus on the Conference includes about new mechanisms for targeting specific Proteins in Blood Stream, Latest uses of Heart Cells in Medicine, Advances in Hematology/ Cardiology, Emerging trends in Stem Cell research, Advancements in Diagnostic & Therapeutic areas of Cardiology, Future directions in Pediatric Cardiology/ Heart Diseases and many more.

The attendees of the Congress will enjoy special events and lectures featuring expertise in the field. It is a perfect platform for Cardiologists, Cardiac Surgeons, immunologists, pathologists, research scholars, University Professors, industrial professionals and student delegates from biomedical and healthcare sectors to explore every single element in Cardiology/ Heart Diseases. Heart Congress 2020 will also provide an excellent opportunity for the budding scientists and young researchers through its special initiatives like Young Researcher Forum, Poster Presentation, B2B and Scientific Meetings.

All the papers to be presented in Heart Congress 2020 will be published in Clinical Cardiology Journal, Current Research: Cardiology, Journal of Cardiology and Clinical Therapeutics.

Conference Highlights:

· Only 45% of the global blood supply is collected in developing countries, which are home to more than 80% of the world’s population.
· 41 out of 148 countries (28%) that provided data on screening for transfusion-transmissible infections including HIV, hepatitis B and C, and syphilis were not able to screen all donated blood for one or more of these infections.
·Heart Failure is often considered a disease of affluence, but about 70% of Heart Diseases deaths occur in low- and middle-income countries.
· A 2012 study in The Lancet Cardiology predicted that from 2008-2030, Heart Diseases incidence will rise 75 percent globally and will double in the least developed countries.
· Sickle cell disease (SCD) affects millions of people throughout the world and is particularly common among those whose ancestors came from sub-Saharan Africa; Spanish-speaking regions in the Western Hemisphere (South America, the Caribbean, and Central America); Saudi Arabia; India; and Mediterranean countries such as Turkey, Greece, and Italy.
· Hemophilia A affects 1 in 5,000 male births. About 400 babies are born with hemophilia A each year.

If you are interested to know more about the Congress,
Contact: Emma Parker
Tel.: +44-203-769-1778
Email: cardionheart@gmail.com, heartcongress@meetingsnexpo.com

FDA Approves Labeling Update for Abbott’s HeartMate 3 Heart Pump for use in Pediatric Patients

  The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more opti...